Cost-utility analysis of fracture risk assessment using microRNAs compared with standard tools and no monitoring in the Austrian female population.

Background: Osteoporosis poses an immense burden to the society in terms of morbidity, mortality and financial cost. To reduce this burden, it is essential to accurately assess the individual patient's fracture risk and, where indicated, to initiate appropriate treatment that reduces fracture probability. Current screening and monitoring approaches include utilization of FRAX®, a web-based country-specific fracture risk assessment tool, and bone mineral density measurement by Dual Energy X-ray Absorptiometry (DXA). Recently, microRNAs have been recognized as important regulators of bone physiology and potential biomarkers for fracture risk assessment and monitoring. A fracture risk assessment tool based on microRNAs (osteomiR™ test) is currently being developed. The aim of this study was to estimate the cost-effectiveness of fracture risk screening, monitoring, and resulting treatment decisions for the Austrian female population using the osteomiR™ test compared with DXA, with FRAX®, or with no screening/monitoring.

Methods: A cost-utility-model was developed to simulate long-term consequences of Austrian women from age 50 over lifetime or death with respect to osteoporosis. Markov-modelling techniques were used to calculate health state transitions of fracture incidence according to risk groups (high, intermediate, low). High-risk patients receive medical treatment. Probabilities were derived via systematic-literature-review; direct costs (2015, €) from published sources from the payer's perspective. Results evaluate the incremental cost-effectiveness ratios (ICER) for osteomiR™ against the comparators, gains or losses of fractures, life years (LYs), quality-adjusted life years (QALYs), and direct costs. QALYs, life years (LYs) and costs were discounted (3% p.a).

Results: Fracture risk assessment and monitoring using the osteomiR™ test reduces fracture incidence compared with no monitoring, DXA alone, or FRAX® alone. In the per-patient analysis, the ICER/QALY of osteomiR™ vs. no-monitoring was 13,103 €, vs. FRAX® 37,813 €, and vs. DXA -19,605 €, indicating that costs can be saved while gaining QALYs. Considering the total cohort over lifetime, the osteomiR™ test can avoid 57,919 fractures compared with DXA, 31,285 fractures compared with FRAX® and 133,394 fractures compared with no monitoring. Sensitivity analysis confirmed the robustness of these findings.

Conclusion: Fracture risk assessment and monitoring using the osteomiR™ test dominates DXA-strategy and constitutes a cost-effective alternative to FRAX®, and no-monitoring, respectively.